Multiple Myeloma

Carfilzomib

Universitätsklinikum Schleswig-Holstein (UKSH) - Division of Stem Cell Transplantation and Immunotherapy, 2nd Department of Medicine

Fo.NE.Sa. Onlus

Divisione di Ematologia A.O.U. Ospedali Riuniti Umberto I - G.M. Lancisi - G. Salesi di Ancona

Carfilzomib In Combination With Bendamustine And Dexamethasone In Refractory Or Relapsed Multiple Myeloma

CARFILZOMIB IN COMBINATION WITH BENDAMUSTINE AND DEXAMETHASONE IN REFRACTORY OR RELAPSED MULTIPLE MYELOMA - A MULTICENTER PHASE IB/II TRIAL OF THE EUROPEAN MYELOMA NETWORK TRIALIST GROUP (EMNTG)

DLTs are defined as the following:
Any CTCAE grade ≥3 non-hematologic event except the following:
1. Nausea or vomiting that responds symptomatic therapy.
Grade 4 neutropenia lasting more than 7 days.
Grade 4 hematologic toxicity except neutropenia
Development of febrile neutropenia defined as grade 3-4 neutropenia with fever 38.5°C and/or infection requiring antibiotic or antifungal treatment. Assessment of DLT defining adverse events will be performed after completion of the second cycle (only in phase Ib) according to the National Cancer Institute Common Terminology Criteria of Adverse Events (CTCAE version 4.0). Efficacy will be assessed by considering VGPR following the proposed regimen, according to the criteria of the International Myeloma Working Group

Determine the rate of very good partial response (VGPR) or more with the CBd association: a VGPR rate of 20% (p0) is considered not promising (H0) and a 40% (p1) as interesting (phase II).

Stichting Hemato-Oncologie voor Volwassenen Nederland

Fondazione Neoplasie Sangue Onlus

Phase I: Cycles 1-4 (1 cycle = 28 days) Lenalidomide: 25 mg per day p.o., day 1 to 21 Dexamethasone: 40/20 mg per day p.o., days 1, 8, 15, 22 Nelfinavir: Dose escalation in cohorts of 3 patients
Phase II: Cycles 1-4 (1 cycle = 28 days) Lenalidomide: 25 mg per day p.o., day 1 to 21 Dexamethasone: 40/20 mg per day p.o., days 1, 8, 15, 22 Nelfinavir: Dose established in phase I twice daily p.o., day 1 to 21

In phase II, the recommended dose of nelfinavir will be administered orally twice daily (in the morning and in the evening) on d1-d21 every 28 days for a maximum of 4 cycles

Nelfinavir

25 mg of lenalidomide (capsules) will be administered orally daily on d1-d21 every 28 days for a maximum of 4 cycles

Lenalidomide

40 mg (for patients <75 years) or 20 mg (for patients ≥75 years) of dexamethasone (tablets) will be administered orally once per day on d1, 8, 15 and 22 every 28 days for a maximum of 4 cycles

Dexamethasone

SAKK - SWISS GROUP FOR CLINICAL CANCER RESEARCH

Istituto Europeo di Oncologia IEO

University of Torino

Kantonsspital Aarau

Kantonsspital Baden

Istituto Oncologico Svizzera Italiana IOSI

Inselspital Bern

Kantonsspital Graubünden

Kantonsspital Olten

Kantonsspital St. Gallen

Regionalspital

UniversitätsSpital Zürich

Nelfinavir and Lenalidomide/Dexamethasone in Progressive Multiple Myeloma

Nelfinavir and Lenalidomide/Dexamethasone in Patients With Progressive Multiple Myeloma That Have Failed Lenalidomide-containing Therapy - A Single Arm Phase I/II Trial

Swiss Group for Clinical Cancer Research

plasmacytoma

braken

vomiting

plasmacytoma/braken

Carfilzomib In Combination With Bendamustine And Dexamethasone In Refractory Or Relapsed Multiple Myeloma

Nelfinavir and Lenalidomide/Dexamethasone in Progressive Multiple Myeloma

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